Field Randomization of NA-1 Therapy in Early Responders

  • STATUS
    Recruiting
  • End date
    May 21, 2022
  • participants needed
    558
  • sponsor
    NoNO Inc.
Updated on 21 July 2021

Summary

The purpose of this study is to determine whether NA-1 is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.

Description

NA-1 is being developed as an emergency drug aimed at reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.

The primary objective is to determine the efficacy of NA-1 in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of NA-1 in reducing functional dependence, improving neurological outcome, improving activities of daily living, and increasing the proportion of subjects who are candidates for endovascular recanalization therapy.

The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of NA-1 within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality.

This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study initiated prehospital in the ambulance. It is being conducted using Emergency Medical Services (EMS) in Canada. Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system, and further screened for eligibility and approval by an on-call trial physician. The paramedics will administer the study drug. Upon arrival at the emergency department, subjects will receive standard-of-care.

An Independent Data Monitoring Committee will perform safety reviews of the clinical data.

Details
Condition Acute Cerebral Ischemia
Treatment Placebo, NA-1
Clinical Study IdentifierNCT02315443
SponsorNoNO Inc.
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool
Respiratory rate 12-24 breaths per minute
Oxygen saturation 90% on room air
Systolic blood pressure < 90 or > 220 mmHg
Weight 45-120 kg
Last seen in usual state of health less than 3 hours before anticipated study drug initiation
Independently ambulatory with or without devices prior to event
LAMS score of 2-5 for at least 15 minutes and remains 2-5 at time of randomization

Exclusion Criteria

Lack of IV access
Canadian Triage and Acuity Scale Level 1 and/or uncorrected airway, breathing or significant circulatory problem
Blood sugar < 3 mmol/L (< 55 mg/dL)
Seizure at onset of symptoms or observed by paramedic
Glasgow coma score of <10
Major head trauma in the last three months
Recent stroke in the last three months with or without residual deficit
Known or presumptive signs of pregnancy or breastfeeding
Prisoner
Long term care facility resident
Known advance directive to not resuscitate
Valid Emergency Health Services Do Not Resuscitate Consent Form
Known participation in a clinical trial with an investigational drug or device within 30 days preceding this trial
Pre-existing neurologic, psychiatric, or advanced systemic condition that would preclude obtaining the neurological or functional outcome evaluations
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